IPD Meta-analysis of De-escalation Treatment Strategy After PCI in ACS
- Conditions
- Acute Coronary SyndromeCoronary Artery Disease
- Interventions
- Drug: De-escalation Treatment Strategy of dual antiplatelet therapy
- Registration Number
- NCT04848766
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
We will perform a systemic review of previously published data and an updated patient-level meta-analysis of studies, including the most recent publications. PubMed, EMBASE, Cochrane Central Register of Controlled Trials, the United States National Institutes of Health registry of clinical trials, and relevant websites were searched for pertinent published studies.
- Detailed Description
This is an individual patient-level data meta-analysis (IPD Meta-analysis). This study population was incorporated from studies that were previoiusly published.
We will perform a systemic review of previously published data and an updated patient-level meta-analysis of studies, including the most recent publications. PubMed, EMBASE, Cochrane Central Register of Controlled Trials, the United States National Institutes of Health registry of clinical trials, and relevant websites were searched for pertinent published studies. The electronic search strategy was complemented by manual examination of references cited by included articles, recent reviews, editorials, and meta-analyses. No restrictions were imposed on language, study period, or sample size. The search keywords include "acute coronary syndrome", "ACS", "primary", "percutaneous coronary intervention", "PCI", "de-escalation", "guided", "guide", "antiplatelet", "P2Y12 inhibitor", "P2Y12", "dual antiplatelet therapy", "DAPT".
Articles were included when they met the following prespecified criteria: (1) included the ACS patients who underwent PCI with drug-eluting stent (DES); (2) maintained DAPT for 1 year; (3) de-escalation strategy of DAPT was clearly defined; (4) clinical outcomes, including ischemic and bleeding events, were clearly reported; (5) randomized controlled trials were considered for inclusion. Two independent investigators screened titles and abstracts, identified duplicated studies, performed full-article reviews, and determined the study inclusion. The third investigator supervised the searching process and adjudicated all the disagreements.
After selecting eligible RCTs, we will incorporate all known randomized controlled trials requesting individual patient data from the principal investigator of each trial.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 9000
- Subject must have clinical diagnosis of acute coronary syndrome
- The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description De-escalation treatment group De-escalation Treatment Strategy of dual antiplatelet therapy Patients diagnosed as acute coronary syndrome, and who receive de-escalation antiplatelet therapy after percutaneous coronary intervention
- Primary Outcome Measures
Name Time Method Net adverse clinical and cerebral events (NACCE) 1 year after intervention composite of all-cause death, myocardial infarction, coronary revascularization, stroke and major bleeding.
- Secondary Outcome Measures
Name Time Method Individual components of the primary outcome 1 year after intervention any bleeding
Major Bleeding outcome defined by the Bleeding Academic Research Consortium (BARC) criteria 1 year after intervention Bleeding outcomes, defined by the Bleeding Academic Research Consortium criteria
Composite endpoint of Major adverse cardiovascular outcomes 1 year after intervention all-cause mortality, myocardial infarction, coronary revascularization, stroke
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of